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4CPS-031 Real-world outcomes of the combination of trifluridine/tipiracil and bevacizumab in metastatic colorectal cancer

ejhpharm · 2026-03-18 · canonical JSON source

15 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Colorectal cancer is the third most diagnosed cancer and the second leading cause of cancer-related mortality. While first- and second-line therapeutic regimens are well established, optimal approach after progression remains uncertain.Therapy with trifluridine/tipiracil (TAS) and bevacizumab (TAS+BEV) has been evaluated in phase III SUNLIGHT trial, demonstrating improved overall survival (OS) compared with TAS monotherapy in adults with metastatic colorectal cancer (mCRC) previously treated with two lines of therapy.Aim and Objectives The aim of this study is to evaluate the efficacy and safety of TAS+BEV in adults with mCRC in routine clinical practice.Material and Methods This retrospective, observational, and multicentre study included patients with mCRC treated with TAS+BEV in four hospitals between January 2023 and July 2025.Patient data (age, sex, Eastern Cooperative Oncology Group (ECOG) performance status, KRAS mutation status, prior treatments) were sourced from electronic medical records.Efficacy was assessed in terms of progression-free survival (PFS) and OS, using the Kaplan–Meier method.Safety was evaluated through the collection of adverse events (AEs) according to Common Terminology Criteria for Adverse Events v5.0, documentation of dose reductions, treatment interruptions, and discontinuations due to toxicity.Results Fifty patients were included (74% male; median age 68 years (43-86)). All had ECOG 0-1 at baseline and median prior treatment lines was 2 (2-5). KRAS mutations were present in 60%.At cut-off date, 24% remained on treatment. Median PFS was 3.9 months (0.27–27.17), median OS 12.4 months (0.27–23.6), and 6-month OS was 68.7%.Grade ≥3 adverse events (AEs) occurred in 30% of patients, including neutropenia, anaemia, thrombocytopenia, and asthenia. Two patients developed febrile neutropenia.Most frequent AEs of any grade were neutropenia (36%), asthenia (30%), thrombocytopenia (20%) and diarrhoea (16%).TAS dose reductions to 30 mg/m2 were required in 30%, with two requiring a further reduction to 25 mg/m2 and 30% experienced treatment delays or discontinuations due to AEs.Conclusion and Relevance The findings are clinically relevant but must be interpreted with caution. The median OS (12.4 months) exceeds the results of the pivotal trial (10.8 months), while median PFS (3.9 months) is slightly lower than in SUNLIGHT (5.6 months).Safety outcomes were consistent with previous evidence.Our findings support and extend existing evidence, although larger studies with longer follow-up are warranted.Conflict of Interest No conflict of interest